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Acute AppendicitisPROADM-APPNCT07889544

Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis

An observational study of Acute Appendicitis, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this prospective observational study is to evaluate the diagnostic accuracy of pro-adrenomedullin (Pro-ADM) in adults with acute appendicitis and compare its performance with conventional inflammatory biomarkers, particularly C-reactive protein (CRP) and the neutrophil-to-lymphocyte ratio (NLR). Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Acute Appendicitis
What is being tested?
Serum Pro-Adrenomedullin Measurement
How many people
400 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2026to 1 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of adults aged 18-90 years evaluated at Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye. The case group includes patients presenting to the emergency department within 48 hours of abdominal pain onset who undergo appendectomy for acute appendicitis. The control group consists of individuals attending outpatient clinics for routine health evaluations without abdominal pain or active inflammatory disease. A total of 400 participants will be prospectively enrolled after providing informed consent.

Who may be able to join

  • Adults aged 18 to 90 years.
  • Patients presenting to the emergency department within 48 hours of the onset of abdominal pain, either directly or following referral from another healthcare institution with a diagnosis or suspicion of acute appendicitis.
  • Patients undergoing appendectomy for acute appendicitis (acute appendicitis group).
  • Individuals attending outpatient clinics for routine health evaluations without abdominal pain or active inflammatory disease (control group).
  • Provision of informed consent for participation in the study.

Who cannot join

  • Age younger than 18 years or older than 90 years.
  • Use of antibiotics or systemic corticosteroids within the preceding month.
  • Active malignancy.
  • Immunosuppressive disease or ongoing immunosuppressive treatment.
  • Abdominal surgery within the preceding three months.
  • Heart failure, renal failure, or liver cirrhosis.
  • Pregnancy or postpartum period.
  • Inability to provide informed consent due to psychiatric disorders.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ulas Karabay, MD contact

+905423157367

dr.ukarabay@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Bursa Yuksek Ihtisas Training and Research Hospital

    Bursa, 16310

    Ugur Duman, MD, +905458177971, ugur.duman@sbu.edu.tr

    Ulas Karabay, MD, +905423157367, dr.ukarabay@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Prospective Comparison of the Diagnostic Accuracy of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio in Acute Appendicitis

The goal of this prospective observational study is to evaluate the diagnostic accuracy of pro-adrenomedullin (Pro-ADM) in adults with acute appendicitis and compare its performance with conventional inflammatory biomarkers, particularly C-reactive protein (CRP) and the neutrophil-to-lymphocyte ratio (NLR).

The main questions are:

Read more
  • How accurately can Pro-ADM distinguish patients with acute appendicitis from healthy controls?
  • How does the diagnostic performance of Pro-ADM compare with that of CRP and NLR?
  • Can Pro-ADM help predict complicated acute appendicitis? Researchers will compare adults undergoing appendectomy for acute appendicitis with healthy individuals attending outpatient clinics for routine evaluations.

Participants will:

  • Provide information about their medical history and clinical characteristics.
  • Undergo blood sampling for Pro-ADM measurement.
  • Have relevant routine laboratory and imaging results recorded. A total of 400 participants will be enrolled. Clinical care and treatment decisions will follow standard medical practice.
Read the detailed description

Background and Rationale Acute appendicitis is a common surgical emergency. Although clinical assessment, laboratory testing, and diagnostic imaging are routinely used, accurate diagnosis may be challenging because of nonspecific symptoms and inflammatory responses.

Conventional inflammatory biomarkers have limitations when used individually. Adrenomedullin is a vasoactive peptide involved in vascular regulation, immune responses, and inflammation. Pro-adrenomedullin (Pro-ADM), a relatively stable biomarker associated with adrenomedullin production, has been investigated in several infectious and inflammatory conditions. However, evidence regarding its diagnostic performance in adult acute appendicitis remains limited.

Study Design and Procedures This prospective, single-center, observational study will include two groups: adults undergoing appendectomy for acute appendicitis and control participants without abdominal pain or active inflammatory disease.

Eligible participants will be enrolled after providing informed consent. Demographic characteristics, medical history, comorbidities, medication use, clinical findings, and diagnostic imaging results will be documented.

Laboratory evaluation will include white blood cell count, neutrophil and lymphocyte counts, neutrophil-to-lymphocyte ratio (NLR), platelet count, C-reactive protein (CRP), blood urea nitrogen, and creatinine. Blood samples will also be collected to measure Pro-ADM concentrations.

Participants will receive standard clinical care. No experimental treatment will be assigned.

Diagnostic Evaluation The primary analysis will assess the diagnostic performance of Pro-ADM in distinguishing patients with acute appendicitis from healthy controls.

Receiver operating characteristic (ROC) curve analysis will be performed, and diagnostic performance will be quantified using the area under the curve (AUC).

The diagnostic performance of Pro-ADM will be compared with that of conventional inflammatory biomarkers. A potentially useful diagnostic cutoff value will be investigated, together with its sensitivity and specificity.

Additional analyses will examine the association between Pro-ADM concentrations and complicated acute appendicitis. Regression models will be used to investigate the independent diagnostic contribution of Pro-ADM.

Statistical Analysis Continuous variables will be summarized using the mean and standard deviation or the median and range, depending on their distribution. Categorical variables will be presented as frequencies and percentages.

Appropriate statistical tests will be used for group comparisons. Chi-square tests will be applied to categorical variables when their assumptions are met.

ROC curve analyses and regression models will be used to evaluate diagnostic discrimination and associations between biomarkers and clinical outcomes.

Statistical analyses will be performed using IBM SPSS Statistics, version 26.

Being tested
Serum Pro-Adrenomedullin Measurement
Keywords
Pro-Adrenomedullin, C-Reactive Protein, Neutrophil-to-Lymphocyte Ratio, Acute Appendicitis
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serum Pro-Adrenomedullin MeasurementDiagnostic test

    Blood samples will be collected from enrolled participants to measure serum pro-adrenomedullin (Pro-ADM) concentrations. Pro-ADM levels will be evaluated and compared with conventional inflammatory biomarkers, including C-reactive protein (CRP), white blood cell count, and neutrophil-to-lymphocyte ratio (NLR), to assess their diagnostic performance in acute appendicitis. The test is performed for research purposes and does not determine clinical treatment allocation.

Study groups in NCT07889544
Study groupRoleWhat they receive
Acute AppendicitisAdult patients aged 18-90 years presenting to the emergency department with suspected acute appendicitis who subsequently undergo appendectomy. Clinical characteristics, imaging findings, conventional inflammatory biomarkers, and serum pro-adrenomedullin (Pro-ADM) concentrations will be prospectively recorded. The diagnostic performance of Pro-ADM will be evaluated in comparison with conventional inflammatory biomarkers.
Receives: Diagnostic Test: Serum Pro-Adrenomedullin Measurement
Healthy ControlsAdult individuals aged 18-90 years attending outpatient clinics for routine health evaluations without abdominal pain or active inflammatory disease. Demographic characteristics and laboratory parameters, including serum pro-adrenomedullin (Pro-ADM), C-reactive protein (CRP), and neutrophil-to-lymphocyte ratio (NLR), will be evaluated for comparison with the acute appendicitis group.
Receives: Diagnostic Test: Serum Pro-Adrenomedullin Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Accuracy of Serum Pro-Adrenomedullin for Acute Appendicitis

    The diagnostic accuracy of serum pro-adrenomedullin (Pro-ADM) for distinguishing patients with acute appendicitis from healthy controls will be assessed using the area under the receiver operating characteristic curve (AUC-ROC). Higher AUC values indicate better diagnostic discrimination. Sensitivity and specificity at the identified diagnostic cutoff will also be calculated.

    Measured: At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.

Secondary outcomes (4)
  1. Comparison of the Diagnostic Accuracy of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio

    The diagnostic performance of Pro-Adrenomedullin (Pro-ADM), C-reactive protein (CRP), and neutrophil-to-lymphocyte ratio (NLR) will be evaluated using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) will be calculated for each biomarker, and their discriminatory performance for acute appendicitis will be compared.

    Measured: At initial clinical assessment (baseline).

  2. Optimal Diagnostic Cutoff Value of Serum Pro-Adrenomedullin

    A diagnostic cutoff value for serum Pro-Adrenomedullin (Pro-ADM) will be identified using receiver operating characteristic (ROC) curve analysis. Diagnostic sensitivity and specificity at the selected cutoff will be calculated to evaluate its ability to distinguish patients with acute appendicitis from healthy controls.

    Measured: At initial clinical assessment (baseline).

  3. Predictive Performance of Serum Pro-Adrenomedullin for Complicated Acute Appendicitis

    The ability of serum Pro-Adrenomedullin (Pro-ADM) concentrations to discriminate complicated from uncomplicated acute appendicitis will be evaluated among patients with acute appendicitis. Receiver operating characteristic (ROC) curve analysis will be used to assess discriminatory performance, expressed as the area under the curve (AUC).

    Measured: From initial clinical assessment to completion of the index hospitalization.

  4. Independent Diagnostic Contribution of Serum Pro-Adrenomedullin

    The independent association between serum Pro-Adrenomedullin (Pro-ADM) concentration and acute appendicitis diagnosis will be evaluated using multivariable regression analysis, adjusting for available conventional inflammatory biomarkers and relevant clinical variables. The adjusted effect estimate and its 95% confidence interval will be reported.

    Measured: At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start1 Aug 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07889544
Sponsor's protocol ID
AA-PROADM-2026-01
Other IDs
2024-TBEK 2026/07-25
Acronym
PROADM-APP
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be made publicly available. The study involves clinical and laboratory data collected from patients and healthy volunteers at a single institution. To protect participant confidentiality and comply with applicable ethical and data protection requirements, individual-level data will not be shared with external researchers. Study findings will be reported in aggregate form through scientific publications and presentations.

Publications

  • Scott AJ, Mason SE, Arunakirinathan M, Reissis Y, Kinross JM, Smith JJ. Risk stratification by the Appendicitis Inflammatory Response score to guide decision-making in patients with suspected appendicitis. Br J Surg. 2015 Apr;102(5):563-72. doi: 10.1002/bjs.9773. Epub 2015 Mar 2.

    PubMed 25727811
  • Oikonomopoulou N, Miguez-Navarro C, Rivas-Garcia A, Garcia Gamiz M, Lopez-Lopez R, Oliver-Saez P, Riano-Mendez B, Farfan-Orte T, Lobato-Salinas Z, Rubies-Olives J, Llena-Isla P, Lancho-Monreal EM; PROADM-DOLOR ABDOMINAL of the research net of the Spanish Society of Pediatric Emergencies (RISEUP-SPERG). Assessment of proadrenomedullin as diagnostic or prognostic biomarker of acute appendicitis in children with acute abdominal pain. Am J Emerg Med. 2019 Jul;37(7):1289-1294. doi: 10.1016/j.ajem.2018.09.038. Epub 2018 Sep 26.

    PubMed 30287129
  • Miguez C, Tomatis Souverbielle C, Haro A, Guerrero G, Perez-Egido L, Garcia-Gamiz M, Maranon R. Evaluation of proadrenomedullin as a diagnostic or prognostic biomarker of acute appendicitis in children. Am J Emerg Med. 2016 Dec;34(12):2298-2305. doi: 10.1016/j.ajem.2016.08.032. Epub 2016 Aug 16.

    PubMed 27609121
  • Temur SA, Baydin A, Tuncel OK, Caliskan S, Yuruker SS. Pro-adrenomedullin: a novel diagnostic biomarker of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2026 Jan;32(1):26-33. doi: 10.14744/tjtes.2025.99491.

    PubMed 41821289

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Appendicitis, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ugur Duman, MD (+905458177971, ugur.duman@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Accuracy of Serum Pro-Adrenomedullin for Acute Appendicitis (time frame: At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07889544, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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